BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6022512 · Received October 12, 2016

    Report

    Report Number
    3004209178-2016-73057
    Event Type
    Death
    Date Received
    October 12, 2016
    Date of Event
    September 10, 2016
    Report Date
    October 8, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. THE CUSTOMER WAS HOSPITALIZED THE SAME DAY OF PASSING. THE CAUSE OF DEATH WAS A MASSIVE HEART ATTACK. THE CALLER STATED THAT BAD HEART, CANCER, AND DIABETES, COMBINED, CONTRIBUTED TO THE CUSTOMER'S DEATH. THE CALLER STATED THAT THE CUSTOMER GOT CANCER IN 2004 AND HEART ISSUES BEGAN IN 2011. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH WAS 40 MG/DL. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER AGREED RETURNING THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671365 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death